Surgical implant for treating pelvic organ prolapse conditions

ABSTRACT

An implant including a vaginal portion having a length, width, first and second ends with a central region positioned therebetween, and a sacral portion having a length, width, first end and second end. The first end of the sacral portion is coupled to the central region of the vaginal portion so that the width of the first end extends substantially perpendicularly to the length of the vaginal portion. The implant is made of the same substantially flat, planar mesh having an anisotropic knitted or woven structure that has a greater stiffness in a first direction than a second direction. The mesh is aligned such that the first direction is aligned in a longitudinal direction of the sacral portion and the mesh of the vaginal portion is aligned such that the stiffness in a longitudinal direction of the vaginal portion is less than that of the sacral portion.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to implants and methods for thetreatment of pelvic organ prolapse conditions, and in particular for thetreatment of vaginal prolapse conditions.

2. Background Discussion

Generally speaking, pelvic organ prolapse occurs when organs orstructures within the pelvic cavity prolapse, or descend from theirnormal anatomical positions. These conditions can include the rectumdescending into the back wall of the vagina to create a bulge that mayaffect bowel function (rectocele), herniation of the small bowel(enterocele), the uterus descending into the normal vaginal space(uterine prolapse), the bladder descending into the vagina typically asa result of a prolapse of the front wall of the vagina (cystocele), oreven the vagina descending into the vaginal cavity itself (vaginal vaultprolapse). Pelvic organ prolapse occurs as a result of weakening ordamage to the muscles and tissues that support the vagina andsurrounding organs that otherwise function to hold them in place, oftendue to the trauma of childbirth, loss of estrogen after menopause, orfollowing a hysterectomy where removal of the uterus affects the normalstructures holding the top of the vagina in place.

Various surgical treatments are available depending on the type andseverity of the prolapse, most of which involve utilizing implantablemeshes or other structures to help provide support to prolapsed organs,or various suspension techniques in which the surgeon attempts toreposition the prolapsed organ and secure or attach it to stronger,intact tissue in the pelvic cavity or to bone or periosteum.

For vaginal vault prolapse, the anatomical defect typically is in oraround the upper portion of the vagina, and treatment involvesreattachment of this portion of the vagina to stronger tissue or to thesacrum to thereby re-suspend the vagina in its normal anatomicalposition.

One known procedure for addressing vaginal vault prolapse utilizes a“Y-mesh” such as the ALYTE® Y-Mesh Graft sold by C.R. Bard, Inc. ofCovington, Ga. The mesh includes first and second vaginal mesh flaps,and a sacral flap extending in the opposite direction from the vaginalmesh flaps. The two vaginal mesh flaps are positioned and secured onopposite surfaces, anterior and posterior, on the upper portion of thevagina. The vagina is then elevated into the proper position, and thesacral flap is attached to the sacral promontory, thereby suspending thevagina in its normal anatomical position.

The Y-mesh described above is comprised of the same mesh structurethroughout, however the vaginal mesh flaps are extended with each endsewn together to form a single, double density sacral flap. Vaginaltissue to which the vaginal mesh flaps are secured, however, is verycomplaint tissue and ideally, the compliance of the mesh should mimicthat of the natural tissue. The sacral flap should have a reasonabledegree of stiffness in the longitudinal direction, as suspension of thevagina from the sacrum is via the sacral flap.

Although compliance of the vaginal flaps is important followingimplantation, it is also desirable that the implant have a reasonabledegree of compliance prior to and during implantation to facilitatehandling by the surgeon. Further, in known procedures, while the surgeonis attaching the first vaginal flap, the second vaginal flap is prone tointerfere (both physical interference and visual obstruction), andtypically requires the surgeon to temporarily restrain the secondvaginal flap while securing the first vaginal flap.

An improved Y-mesh type implant having improved compliance propertiesand features would be highly desirable.

SUMMARY OF THE INVENTION

The present invention provides a surgical implant including a vaginalportion having a length, a width, a first end and a second end, and acentral region positioned between the first and second ends, and asacral portion having a length, a width, a first end and a second end,the first end of the sacral portion being coupled to the central regionof the vaginal portion so that the width of the first end extendssubstantially perpendicularly to the length of the vaginal portion. Thevaginal and sacral portions are made of the same substantially flat,planar mesh having substantially uniform properties throughout theimplant and having a anisotropic knitted or woven structure that has agreater stiffness in a first direction than a second direction. The meshof the sacral mesh portion is aligned such that the first direction isaligned in a longitudinal direction of the sacral portion and the meshof the vaginal portion is aligned such that the stiffness in alongitudinal direction of the vaginal portion is less than that of thesacral portion. According to one embodiment, the mesh is a partiallyabsorbable mesh, that may further be made of a substantially equal massof poliglecaprone-25 monofilament fibers and absorbable polypropylenemonofilament fibers.

In another embodiment, the mesh of the vaginal portion is oriented in afirst direction and the mesh of the sacral portion is oriented in asecond direction that is substantially perpendicular to the firstdirection.

The surgical implant may further include an absorbable film coupled toat least the sacral portion of the mesh.

In alternate embodiments, the sacral portion is coupled to the vaginalportion by a sewn seam or by a laser weld.

In yet further alternate embodiments, the length and width of the sacralportion is approximately 14 cm and 3 cm respectively, and the length andwidth of the vaginal portion is approximately 13 cm and 5 cmrespectively.

The vaginal portion may be made of a first vaginal flap extending fromthe central region to the first end, and a second vaginal flap extendingfrom the central region to the second end, wherein at least one of thefirst and second vaginal flaps is biased to overlay the sacral portionwhen the implant is unconstrained.

Also provided is a surgical implant having a vaginal portion having alength, a width, a first end and a second end, and a central regionpositioned between the first and second ends. The vaginal portion ismade of a mesh having a knit or weave pattern oriented in a firstdirection. The implant further includes a sacral portion having alength, a width, a first end and a second end, where the first end ofthe sacral portion is coupled to the central region of the vaginalportion so that the width of the first end extends substantiallyperpendicularly to the length of the vaginal portion. The sacral portionis comprised of the same mesh as the vaginal portion, and has a knit orweave pattern oriented in a second direction different than the firstdirection. In one embodiment, the second direction is substantiallyperpendicular to the first direction.

In another embodiment, the mesh is a partially absorbable mesh, whichmay be made of a substantially equal mass of poliglecaprone-25monofilament fibers and absorbable polypropylene monofilament fibers.

The implant may further include an absorbable film coupled to at leastthe sacral portion of the mesh.

In yet another embodiment, the vaginal portion is made of a firstvaginal flap extending from the central region to the first end, and asecond vaginal flap extending from the central region to the second end,wherein at least one of the first and second vaginal flaps is biased tooverlay the sacral portion when the implant is unconstrained.

Also provided is a surgical implant including a vaginal portion having alength, a width, a first end, a second end, and a central regionpositioned between the first and the second ends. The vaginal portionincludes a first vaginal flap portion extending from the central regionand terminating at said first end, and a second vaginal flap portionextending from the central region and terminating at said second end.The implant further includes a sacral portion having a length, a width,a first end and a second end, with the first end being coupled to thecentral region of the vaginal portion so that the first end of thesacral portion extends substantially perpendicularly to the length ofthe vaginal portion. At least the first vaginal flap is biased tosubstantially overlay the sacral portion when unconstrained. The implantmay be made of a mesh, which may be partially absorbable and may furtherbe made of a substantially equal mass of poliglecaprone-25 monofilamentfibers and absorbable polypropylene monofilament fibers.

In yet another embodiment, at least one of the first and second vaginalflaps is biased to overlay the sacral portion when the implant isunconstrained.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of a surgical implantaccording to the present invention;

FIG. 2 is a side view illustrating the implant of FIG. 1 positionedwithin a patient;

FIG. 3 is a plan view of an unassembled package suitable for use withthe implant of FIG. 1;

FIGS. 4 a-4 d illustrate various steps for assembling the package ofFIG. 3 to hold the implant of FIG. 1;

FIGS. 4 e-4 f illustrate the combination implant and package fullyassembled; and

FIG. 5 illustrates the implant of FIG. 1 after packaging andsterilization according to another aspect of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Before explaining the present invention in detail, it should be notedthat the invention is not limited in its application or use to thedetails of construction and arrangement of parts illustrated in theaccompanying drawings and description. The illustrative embodiments ofthe invention may be implemented or incorporated in other embodiments,variations and modifications, and may be practiced or carried out invarious ways.

One embodiment of a surgical implant 100 according to the presentinvention, and its use within a patient is illustrated in FIGS. 1 and 2.The implant 100 includes a vaginal portion 102 that is designed to besecured to vaginal tissue, and a sacral portion 103 that is secured tothe sacrum 113 and operates to suspend the vaginal cuff 110 in theproper anatomical position. The vaginal portion is preferably made of asingle continuous material that includes a first vaginal flap 104 and asecond vaginal flap 105. The first vaginal flap 104 is attached to theanterior surface 114 of the vaginal wall and the second vaginal flap 105is attached to the posterior surface 116 of the vaginal wall asillustrated in FIG. 2.

In one embodiment, the length L₁ and width W₁ of the sacral portion areapproximately 14 cm and 3 cm respectively, and the length L₂ and widthW₂ of each vaginal portion are approximately 13 cm and 5 cmrespectively.

In a preferred embodiment, the entirety of the implant is comprised of athe same, substantially flat, uniform mesh structure, which optimally iscomprised of equal parts of absorbable poliglecaprone-25 monofilamentfibers and non-absorbable polypropylene monofilament fibers. A meshcomprised of these materials and having a suitable knitting constructionis commercially available as GYNEMESH M™ Partially Absorbable Mesh, andis manufactured and sold by Ethicon, Inc. of Somerville, N.J. As will bedescribed further below, the partially absorbable nature of this meshprovides superior characteristics with regard to improved handling ofthe mesh in the surgical setting prior to hydrolysis of the absorbablecomponents, and improved compliance following hydrolysis after it hasbeen implanted, which is particularly important when secured to tissuesuch as highly compliant vaginal tissue. In one embodiment, selectedpolypropylene fibers may be dyed to help visually aid the surgeon duringpositioning, trimming and/or suturing of the implant. For example,longitudinal strands or strands extending laterally across the width maybe dyed to indicate the direction of the mesh. Further, equal spacing ofthe strands may be used to indicate distances and/or sizes of the mesh.

The mesh material described above has a knitted construction that isanisotropic, meaning that because of the knit pattern, the mesh hasdifferent properties in one direction (i.e., longitudinally) than itdoes in a different direction. For implants of this type, it isdesirable that the sacral flap have a greater stiffness in thelongitudinal direction to enable it to have the necessary supportsuspend the vagina from the sacrum. For the vaginal flaps, however, alower stiffness is desirable to better approximate the compliant tissueproperties of the vaginal tissue. According to one embodiment, althoughthe same, uniform mesh material is used across the entire implant, thedirectional orientation of the mesh in the vaginal flaps is differentfrom that in the sacral flap. The mesh of the sacral portion may bealigned so that its greatest stiffness is in the longitudinal direction,and the mesh of the vaginal portions may be aligned so as to have theleast or simply less stiffness in the longitudinal direction. In oneembodiment, the two are oriented substantially perpendicularly to oneanother. Further, additional temporary stiffening and also stressshielding of the mesh (keeping the mesh undistorted until the filmdegrades) may be achieved by applying an absorbable film, such aspolydioxanone (PDO), to all or selected portions of the mesh.

Perpendicular alignment of the sacral and vaginal portions can beachieved by securing a first end 110 of a separate sacral flap to asubstantially central region 112 of a separate vaginal portion. Thesecomponents can be secured by any suitable manner, such as by a sewnseam, laser welding or the like. In a preferred embodiment, a seam isformed by sewing with polypropylene threads along the edge of the meshand tied to the crossing with perpendicular threads, which resembles themesh itself and largely retains the properties of the mesh in terms ofelasticity in all directions, and the properties of the mesh in terms ofmechanics and porosity.

As indicated previously, in a preferred embodiment, the mesh iscomprised of the commercially available product GYNEMESH M™ PartiallyAbsorbable Mesh. This mesh has an average pore size of 3.9 mm² beforehydrolysis, and an average pore size of 4.6 mm² after hydrolysis (about84 days). Known competitive meshes are comprised of all non-absorbablepolypropylene and thus have a consistent pore size and amount ofmaterial that remains within the body. For example, the ALYTE® Y-MeshGraft has a constant pore size of 2.01 mm² (sacral portion), and thushas a higher density of material remaining within the body. Further, thepresently described implant has the following stiffness properties priorto and following hydrolysis:

Pre-Hydrolysis Post-Hydrolysis Bending Stiffness (Sacral Portion) 454mg-cm 179 mg-cm Bending Stiffness (Vaginal Portion) 139 mg-cm  18 mg-cmAs a point of comparison, the ALYTE® Y-Mesh Graft has a sacral portionbending stiffness of 205 mg/cm and a vaginal portion bending stiffnessof 86.1 mg/cm. Thus, the present device has far superior post-hydrolysisproperties, particularly for the vaginal portion (18 mg/cm as comparedto 86.1 mg/cm) which allows the implant to much better mimic the verycompliant vaginal tissue. The sacral portion of the present device alsohas far superior bending stiffness prior to hydrolysis to aid in surgeonhandling and initial suspension, and somewhat lower stiffness followinghydrolysis for better compliance after implantation.

According to another aspect of the present invention, at least one, andpreferably both, of the two vaginal flaps is formed to include a bendacross its width such that the vaginal flap is biased to laysubstantially over the sacral flap when unconstrained. This feature ishighly advantageous in the surgical setting. In the known productsdescribed above, the vaginal flaps are biased to lay substantially overone another when unconstrained and with the sacral flap extending in theopposite direction. During surgical implantation, however, as thesurgeon is attaching the first of the vaginal flap, the second vaginalflap physically and visually impairs the surgeon, and often requiresthat the second vaginal flap be tacked up out of the way, typically bytemporarily suturing the second vaginal flap to the sacral flap. With abiased flap as described herein, the second vaginal flap remains out ofthe way, and does not require temporary fixation or the like.

The biasing of the vaginal flap can be accomplished by pre-forming themesh material, or more preferably is formed by specially designedpackaging in combination with a sterilization process. An implant havingthe biased vaginal flaps resulting from packaging and sterilization isbest shown in FIG. 5. Following fabrication and before packaging andsterilization, the implant lays substantially flat with the sacralportion 103 laying substantially flat over the first vaginal flap 104and the second vaginal flap 105 laying substantially flat and extendingin the opposite direction. Following packaging and sterilization, bothvaginal flaps have a bend along their respective lengths and are biasedto bend back over the sacral flap as shown in FIG. 5.

One embodiment of a package that can be utilized to achieve biasing ofthe flaps as described above is illustrated in FIGS. 3 and 4 a-4 f. Asbest shown in FIG. 3, the package 300 includes a substantially flat,first center panel 302 extending along longitudinal axis A-A, aperiphery of which is defined by first and second longitudinal edges303, 304 and first and second lateral edges 305, 306. A substantiallyflat, second center panel 308 also extends along the longitudinal axis,and has a periphery defined by third and fourth longitudinal edges 309,310 and third and fourth lateral edges 311, 312. At least a portion ofthe fourth longitudinal edge 310 is adjacent to and physically coupledwith the first longitudinal edge 303 of the first center panel 302 asshown. The package further includes first and second lateral panels 314,320 that extend longitudinally. The first lateral panel 314 is definedby fifth and sixth longitudinal edges 315, 316 and fifth and sixthlateral edges 317, 318. Similarly, the second lateral panel 320 isdefined by seventh and eighth longitudinal edges 321, 322 and seventhand eighth lateral edges 323, 324. The first lateral panel is adjacentto and substantially aligned with the first center panel, and is coupledthereto along at least a portion of the respective fifth and firstlongitudinal edges. Similarly, the second lateral panel is adjacent toand substantially aligned with the first center panel, and is coupledthereto along at least a portion of the respective sixth and secondlongitudinal edges. The panels preferably are coupled to one another ata bendable seam or the like, so that the panels may movably be foldedover one another at the seams. The package further includes a thirdlateral panel 330 also extending in the longitudinal direction butpositioned lateral of the first lateral panel. The third lateral panelis defined by ninth and tenth longitudinal edges 331, 332 and ninth andtenth lateral edges 333, 334. The ninth lateral edge 331 issubstantially aligned with and coupled to, along at least part of itslength, the sixth lateral edge 315 of the first center panel.

The manner in which the package 300 is assembled and holds the implantof the present invention is best illustrated by FIGS. 4 a-4 f. Theimplant 100 is positioned so that the first vaginal flap 104 ispositioned substantially on top of the first center panel 302 and thesecond vaginal flap 105 and sacral flap 103 extend outwardly from thesecond longitudinal edge 304 and exterior to the package.

The second center panel 308 is then folded over the first center panel302, and the sacral portion 103 positioned over the second center panelas shown in FIG. 4 b. Subsequently, the second lateral panel 320 isfolded over the sacral portion, and the second vaginal flap 105 ispositioned substantially over the second lateral panel as shown in FIG.4 c. The first lateral panel 314 is then folded over the second vaginalflap 105 and the third lateral panel 330 folded over to the complete thepackage as shown in FIG. 4 d. The second lateral panel 314 may furtherinclude a foldable end portion 340 that, once the package is assembled,can be folded down to reveal the implant as shown in FIG. 4 e, such thatthe user can grasp the implant to remove it from the package as shown inFIG. 4 f with one hand and in one step, without any further unfolding ordisassembly of the package.

As described above, the implant is packaged so that the three mesh flapsare aligned substantially on top of one another, but are each separatedby a panel of the package. In this manner one of the three flaps lies inan unconstrained position, while two of the three flaps that are foldedback over the first one are held in that biased or constrained position.Once the package and implant are assembled, the entire assembly issterilized by any suitable manner such as ethylene oxide. Thesterilization process causes the biased mesh flaps to take on a “heatset”, such that once dispensed from the package these flaps are nowbiased toward the packaged position, which results in at least one ofthe vaginal flaps to remain biased to fold over the sacral flap. Asindicated previously, this is advantageous during surgical implantation,as it overcomes the previously known problem of having the secondvaginal flap physically and visually obstructing the is surgeon whilesecuring the first vaginal flap, and avoids to the need to temporarilysuture or tack the second vaginal flap out of the way.

It will be apparent from the foregoing that, while particular forms ofthe invention have been illustrated and described, various modificationscan be made without departing from the spirit and scope of theinvention. Accordingly, it is not intended that the invention belimited, except as by the appended claims.

What is claimed is:
 1. A surgical implant comprising: a vaginal portionhaving a length, a width, a first end and a second end, and a centralregion positioned between the first and second ends; a sacral portionhaving a length, a width, a first end and a second end, the first end ofthe sacral portion being coupled to the central region of the vaginalportion so that the width of the first end extends substantiallyperpendicularly to the length of the vaginal portion; wherein thevaginal and sacral portions are comprised of the same substantiallyflat, planar mesh having substantially uniform properties throughoutsaid implant and having an anisotropic knitted or woven structure thathas a greater stiffness in a first direction than a second direction,and wherein the mesh of the sacral mesh portion is aligned such that thefirst direction is aligned in a longitudinal direction of the sacralportion and the mesh of the vaginal portion is aligned such that thestiffness in a longitudinal direction of the vaginal portion is lessthan that of the sacral portion.
 2. The surgical implant according toclaim 1, wherein the mesh is a partially absorbable mesh.
 3. Thesurgical implant according to claim 2, wherein the mesh is comprised ofa substantially equal mass of poliglecaprone-25 monofilament fibers andabsorbable polypropylene monofilament fibers.
 4. The surgical implantaccording to claim 1, wherein the mesh of the vaginal portion isoriented in a first direction and the mesh of the sacral portion isoriented in a second direction that is substantially perpendicular tothe first direction.
 5. The surgical implant according to claim 1,further comprising an absorbable film coupled to at least the sacralportion of the mesh.
 6. The surgical implant according to claim 1,wherein the sacral portion is coupled to the vaginal portion by a sewnseam.
 7. The surgical implant according to claim 1, wherein the sacralportion is coupled to the vaginal portion by a laser weld.
 8. Thesurgical implant according to claim 1, wherein the length and width ofthe sacral portion is approximately 14 cm and 3 cm respectively.
 9. Thesurgical implant according to claim 8, wherein the length and width ofthe vaginal portion is approximately 13 cm and 5 cm respectively. 10.The surgical implant according to claim 1, wherein the vaginal portionis comprised of a first vaginal flap extending from the central regionto the first end, and a second vaginal flap extending from the centralregion to the second end, and wherein at least one of the first andsecond vaginal flaps is biased to overlay the sacral portion when theimplant is unconstrained.
 11. A surgical implant comprising: a vaginalportion having a length, a width, a first end and a second end, and acentral region positioned between the first and second ends, the vaginalportion being comprised of a mesh having a knit or weave patternoriented in a first direction; a sacral portion having a length, awidth, a first end and a second end, the first end of the sacral portionbeing coupled to the central region of the vaginal portion so that thewidth of the first end extends substantially perpendicularly to thelength of the vaginal portion, the sacral portion being comprised of thesame mesh as the vaginal portion, and having a knit or weave patternoriented in a second direction different than said first direction. 12.The surgical implant according to claim 11, wherein the second directionis substantially perpendicular to the first direction.
 13. The surgicalimplant according to claim 11, wherein the mesh is a partiallyabsorbable mesh.
 14. The surgical implant according to claim 13, whereinthe mesh is comprised of a substantially equal mass of poliglecaprone-25monofilament fibers and absorbable polypropylene monofilament fibers.15. The surgical implant according to claim 11, further comprising anabsorbable film coupled to at least the sacral portion of the mesh. 16.The surgical implant according to claim 11, wherein the length and widthof the sacral portion is approximately 14 cm and 3 cm respectively. 17.The surgical implant according to claim 16, wherein the length and widthof the vaginal portion is approximately 13 cm and 5 cm respectively. 18.The surgical implant according to claim 11, wherein the vaginal portionis comprised of a first vaginal flap extending from the central regionto the first end, and a second vaginal flap extending from the centralregion to the second end, and wherein at least one of the first andsecond vaginal flaps is biased to overlay the sacral portion when theimplant is unconstrained.
 19. A surgical implant comprising: a vaginalportion having a length, a width, a first end, a second end, and acentral region positioned between the first and the second ends, thevaginal portion including a first vaginal flap portion extending fromthe central region and terminating at said first end, and a secondvaginal flap portion extending from the central region and terminatingat said second end; a sacral portion having a length, a width, a firstend and a second end, the first end being coupled to the central regionof the vaginal portion so that the first end of the sacral portionextends substantially perpendicularly to the length of the vaginalportion; wherein at least the first vaginal flap is biased tosubstantially overlay the sacral portion when unconstrained.
 20. Thesurgical implant according to claim 19, wherein the implant is comprisedof a mesh.
 21. The surgical implant according to claim 20, wherein themesh is partially absorbable.
 22. The surgical implant according toclaim 21, wherein the mesh is comprised of a substantially equal mass ofpoliglecaprone-25 monofilament fibers and absorbable polypropylenemonofilament fibers.
 23. The surgical implant according to claim 20,wherein the length and width of the sacral portion is approximately 14cm and 3 cm respectively.
 24. The surgical implant according to claim23, wherein the length and width of the vaginal portion is approximately13 cm and 5 cm respectively.
 25. The surgical implant according to claim19, wherein at least one of the first and second vaginal flaps is biasedto overlay the sacral portion when the implant is unconstrained.